Clinician, Companion Animal Clinical Development at Zoetis in Parsippany-Troy Hills, New Jersey
Disabledperson, Inc
Companion Animal Clinical Development Clinician
Zoetis is currently seeking a Companion Animal Clinical Development Clinician to join our team. In this role, you will design and execute companion animal pharmaceutical and biopharmaceutical clinical development studies in compliance with U.S. CVM/CVB regulatory requirements. You will deliver pilot and pivotal clinical studies that support product registrations and provide expertise in companion animal medicine and study conduct to research and development phase projects.
Responsibilities
- Lead the overall conduct of clinical studies in support of Veterinary Medicine Research & Development (VMRD) companion animal R&D projects, including:
- Budget development and management
- Investigator and site selection
- Protocol development and writing
- Study monitoring
- Data analysis and interpretation
- Report writing and preparation of technical sections for regulatory dossiers
- Ensure studies are conducted in compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory guidelines (e.g., Good Clinical Practice and Good Laboratory Practice).
- Collaborate with Clinical and Project Teams to define and track study status, activities, timelines, and outcomes. Identify resource, timeline, and/or budget constraints and work with the Project Manager and Project Team Leader to develop appropriate solutions.
- Partner with Regulatory Affairs to obtain protocol approval and support submission of reports and data to the Center for Veterinary Medicine (CVM) and/or the Center for Veterinary Biologics (CVB), USDA. May also contribute to studies supporting regulatory approvals in the EU and other international markets.
Education and Experience
Minimum Qualifications:
- Doctor of Veterinary Medicine (DVM)
- Minimum of 3 years of experience in U.S. companion animal private practice
- Experience managing clinical cases involving therapeutics and/or biologics in companion animals
- Experience designing or contributing to clinical protocols or research studies
Preferred Qualifications:
- PhD
- Board Certification in a companion animal discipline
- Working knowledge of U.S. regulatory requirements for animal health products, including Center for Veterinary Medicine (CVM) and Center for Veterinary Biologics (CVB) guidelines
- Experience in companion animal clinical development within the Animal Health industry Experience interacting with regulatory agencies (e.g., technical section authorship or direct communication with CVM/CVB)
- Prior authorship of regulatory dossiers supporting product approvals
- Experience with global regulatory submissions (EU, Canada, Australia, etc.)
- Familiarity with pharmacovigilance and post-marketing surveillance requirements
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS)
- Demonstrated leadership of cross-functional teams in a matrixed organization
- Experience managing CROs and external study sites
- Publication record in peer-reviewed veterinary journals
- Advanced training in clinical pharmacology, epidemiology, or translational medicine
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